Vincristine, Doxorubicin, Cyclophosphamide and Dexrazoxane (VACdxr) in High Risk Ewing's Sarcoma Patients

• Status: Terminated
• Trial end date: 2016-03-01
• Target enrollment: 0
• Participant gender: All

Summary

Objectives:

1. To determine if dose intensive Vincristine, Doxorubicin, Cyclophosphamide and Dexrazoxane (VACdxr) with or without ImmTherTM can improve the 2-year disease-free survival seen with standard VAC therapy.

2. To evaluate the feasibility and describe the toxicity associated with VACdxr.

3. To evaluate the feasibility and describe the toxicity of administering ImmTherTM on a weekly basis for 50- 52 weeks.

4. To determine which therapy (VACdxr+ or VACdxr-) is worthy of further evaluation.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: M.D. Anderson Cancer Center
• Treatments: Acetylmuramyl-Alanyl-Isoglutamine; Cyclophosphamide; Dexrazoxane; Doxorubicin; Liposomal doxorubicin; Razoxane; Vincristine

Criteria

Inclusion Criteria:

• High risk Ewing's Family of tumors (metastatic disease at diagnosis, humerus, femur or trunk primary, bulky primary (greater than 8 cm)), or LDH greater or equal to 900 IU/ml prior to biopsy.

• No prior chemotherapy.

• Written informed consent

• Normal cardiac function (ejection fraction greater or equal to 50%).

• Males and non pregnant females.

• Biologic age 3-60 years old.

• Adequate bone marrow function (defined as an absolute peripheral granulocyte count of>500/mm3, platelet count of >75,000/mm3, and hemoglobin >8g/dl with transfusion if required).

• Adequate renal function defined as blood urea nitrogen (BUN) <30mg% and serum creatinine <1.5 x normal for age or creatinine clearance >70.

• Patients of child bearing potential must agree to use an effective method of contraception.

• Normal hepatic function (bilirubin <1.5mg/dl, serum glutamate oxaloacetate transaminase (SGOT) or serum glutamate pyruvate transaminase (SGPT) <3x normal).

Exclusion Criteria: N/A